Past the patent cliff, pharmas are set for rebound in NMEs, says IMS

Industry pipelines might not be brimful of blockbusters, but after years of meager output, biopharma firms are poised to tap a cornucopia of innovative treatments as thirty-something New Molecular Entities launch each year through 2016.

That's the silver lining in IMS's latest Global Use of Medicines Outlook report. The downside: the next two years will be ugly, as major players continue to suffer patent expiries on key products and generics eat up an ever-larger share of the pie.

IMS forecasts 32-37 innovative products to launch per year over the next five years, including new mechanisms of action in Alzheimer's, autoimmune disorders, diabetes, a number of cancers and orphan diseases. That's an appreciable bump over the 25-30 NMEs seen in each of the last five years. IMS tabulates 140 NMEs launched between 2006 and 2010, versus an estimated 160-185 between 2012 and 2016.

“We're not talking a return to the late ‘90s of the early 2000s, when there were forty or more some years, and they're not all mega-blockbuster products,” said IMS research chief Michael Kleinrock. “There will be more specialty, there will be new mechanisms of action for therapeutic areas and orphan drugs.”

Many of those new mechanisms will come in clusters of drugs (bapineuzumab and solanezumab for Alzheimer's, the gliflozins for diabetes), giving patients options and making marketers work to differentiate their products.

The new drug boomlet is, in part, a cyclical swell, as seeds planted two decades back in academic and government research come to fruition, but the boomlet reflects, in part, a number of drugs that faced delays in approval belatedly making it to market, says Kleinrock, noting the Arena/Eisai drug Belviq (lorcaserin).

Global spending will hit $1.2 trillion by 2016, with branded drug spend accounting for between $615 and $645 billion and generics spending between $400 and $430 billion. IMS forecasts global growth of 3-4% this year, a low point largely due to the impact of US patent losses, but rising to 5-7% by 2016, thanks to strong growth from emerging markets driven by rising incomes and increased access through government policies and programs in those regions. In the US, spending will average between 1-4% through 2016, while emerging markets will see 12-15% growth.

That growth, of course, will be driven by volume and will go almost exclusively to generics. The 17 countries IMS calls “pharmerging” markets spend an average of $91 per person annually on healthcare, whereas developed countries spend an average of $609. Nonetheless, those emerging markets will account for 30% of global spending by 2016, thanks to explosive population and economic growth.

The US will account for less than a third of global drug spending by 2016 – 31%, compared to 41% in 2006 – but will still easily make up the largest slice of the geographic pie.

“Rumors to the contrary, the US market is still alive and well,” said Kleinrock. “The patent cliff will take some of those dollars out of the mix, but once it's past its peak this year and next, we're going to see a significant rebound in what's available for both branded and generics companies.”